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Drug Catalog - Product Detail

TIMOLOL MALEATE OPHTH SOL 0.005 10ML

NDC Mfr Size Str Form
64980-0514-01 RISING PHARMACEUTICALS 10 0.5% SOLUTION
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PACKAGE FILES

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Generic Name
TIMOLOL MALEATE
Substance Name
TIMOLOL MALEATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA077259
Description
DESCRIPTION Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is: Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 and its structural formula is: Image Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative. Timolol Optical Rotation Timolol Structure
How Supplied
HOW SUPPLIED Sterile ophthalmic solution of timolol maleate is a clear, colorless solution. Timolol maleate ophthalmic solution USP, 0.25% timolol equivalent, is supplied in a labeled translucent LDPE bottle with insert cap assembly comprising of a yellow colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the bottle cap. NDC 64980-513-05, 5 mL in a 5 mL bottle NDC 64980-513-01, 10 mL in a 10 mL bottle NDC 64980-513-15, 15 mL in a 15 mL bottle Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a labeled translucent LDPE bottle with insert cap assembly comprising of a yellow colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the bottle cap. NDC 64980-514-05, 5 mL in a 5 mL bottle NDC 64980-514-01, 10 mL in a 10 mL bottle NDC 64980-514-15, 15 mL in a 15 mL bottle Storage Store at 15°C to 25°C (59°F to 77°F). Protect from freezing. Protect from light. After opening, timolol maleate ophthalmic solution can be used until the expiration date on the bottle.
Indications & Usage
INDICATIONS AND USAGE Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage and Administration
DOSAGE AND ADMINISTRATION Timolol maleate ophthalmic solution is available in concentrations of 0.25 and 0.5 %. The usual starting dose is one drop of timolol maleate ophthalmic solution 0.25 % in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 % solution in the affected eye(s) twice a day. Since in some patients the pressure-lowering response to timolol maleate ophthalmic solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol maleate ophthalmic solution. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. Dosages above one drop of timolol maleate ophthalmic solution 0.5 % twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. [See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents ]